Kornimate/medical-research-clean huggingface dataset:
s-33 smr shoulder hp reverse glenosphere

Conditions: Arthroplasty, Replacement, Shoulder

Summary: study design: single arm, retrospective and prospective, single center, post-market clinical study purpose:to demonstrate the safety and effectiveness of the smr reverse hp shoulder system device for primary, fracture or revision total shoulder replacement out to 24 months. the eligible study population is the entire population that underwent a reverse shoulder arthroplasty performed with 36-mm cocrmo versus 40-mm cross-linked uhmwpe glenospheres between january 1, 2013 and january 1, 2020 at wrightington hospital (uk) in accordance with the indication for use of the product.


Eligibility criteria:
inclusion criteria: 1. patient was treated with the smr reverse shoulder system device (either with 36-mm cocrmo glenosphere or 40-mm cross-linked uhmwpe glenosphere) between january 1, 2013 and january 1, 2020 as per instruction for use 2. patient was an adult male or female and was 18 years of age or older at the time of surgery 3. patient received the smr reverse shoulder system for primary, fracture, or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthroplasty 4. the patient's joint was anatomically and structurally suited to receive the selected implants, with a functional deltoid muscle 5. surgery date is at least 24 months from screening of data 6. patient has baseline radiographs and oxford shoulder score exclusion criteria: 1 patient was treated with the smr reverse shoulder system device (either with 36-mm cocrmo glenosphere or 40-mm cross-linked uhmwpe glenosphere) between january 1, 2013 and january 1, 2020 out of the indications for use
a trial of cs-747 (prasugrel) compared with clopidogrel in patients undergoing percutaneous coronary intervention (pci)

Conditions: Cardiovascular Diseases; Heart Diseases

Summary: the purpose of this study is to evaluate the effects of a drug known as cs-747 (also known as prasugrel) on subjects having a procedure called a percutaneous coronary intervention (also referred to as pci) in which a doctor will attempt to open a blocked vessel (or vessels) in the heart using a catheter (a long thin tube) that has a small balloon on the end. in many cases, patients who have this procedure receive a stent, a small wire spring that helps keep the vessel open.


Eligibility criteria:
inclusion criteria: * patients must be candidates for elective or urgent pci with intended coronary stenting. * men or non-pregnant women (that is, postmenopausal women, women who are surgically sterile, or women of childbearing potential who have a negative urine or serum pregnancy test) who are greater than or equal to 18 and less than or equal to 75 years of age. exclusion criteria: * patients must not have planned pci procedure as initial treatment for an acute st-elevation acute myocardial infarction (stemi) * patients must not be receiving or will receive oral anticoagulation therapy that cannot be safely discontinued for the duration of the study * patients must not have cardiogenic shock or severe congestive heart failure * patients must not have active internal bleeding or history of bleeding diathesis * patients must not have prior history of hemorrhagic cerebrovascular accident (cva) or nonhemorrhagic cva within 2 years of enrollment
study of anastrozole +/- azd8931 in postmenopausal women with endocrine therapy naive breast cancer

Conditions: Neoplasms; Breast Neoplasms; Breast Cancer

Summary: the main purpose of this study is to compare progression free survival in patients treated with azd8931 given in combination with anastrozole versus anastrozole alone. the secondary objective is to investigate the safety and tolerability of azd8931 given in combination with anastrozole.


Eligibility criteria:
inclusion criteria: * patients that have locally advanced or metastatic breast cancer. lesions should not be amenable to surgery or radiation of curative intent * hormone therapy-naive * estimated life expectancy of more than 12 weeks exclusion criteria: * last dose of prior anti-cancer therapy received within 14 days (or longer if required) * any eye injury or corneal surgery within 3 months prior to receiving first dose of study drug. * currently receiving (and unwilling to discontinue) oestrogen replacement therapy. (last dose \<7 days prior to randomisation)

Keywords: cancer tumour breast cancer metastatic secondary locally advanced
study on theraputic drug monitoring and phamacokinetics of isavuconazole in children

Conditions: Aspergillosis Invasive; Mucormycosis

Summary: the goal of this clinical trial is to learn the plasma concentration of isavuconazole in pediatric patients. it will also learn about the relationship of isavuconazole plasma concentrations to efficacy and safety in pediatric patients. the main questions it aims to answer are: what is the plasma concentration after using isavuconazole in pediatric patients? what is the effective range of plasma concentration of isavuconazole in pediatric patients? what is the safe range of plasma concentration of isavuconazole in pediatric patients? researchers will measure the plasma concentration of isavuconazole to see whether it is appropriate. participants will: take drug isavuconazole as prescribed by the doctor; 1ml of blood is drawn 30min before the next dose.

objectives of study: main objective: to monitor the plasma concentration of isavuconazole in children, and to study the pharmacokinetic characteristics of isavuconazole in children, so as to provide basis for the optimization of individualized drug administration. secondary objective: to evaluate the relevance of isavuconazole plasma concentrations to efficacy and safety in pediatric patients.

Eligibility criteria:
inclusion criteria: * patients who intend to take isavuconazole for the treatment of invasive mycosis; * aged 0-18 years, gender unlimited; * the subject and his/her guardian are willing to comply with the procedures and operations specified in the study protocol; * the guardian of the subject and the subject of independent informed age are willing and able to provide written informed consent to participate in the study. exclusion criteria: * the subject is known to be allergic to any azole antifungal therapy or other ingredients contained in the study drug; * the researcher believes that the condition of the child may interfere with study participation or other inappropriate conditions.
a study to evaluate the efficacy and safety of erenumab (amg 334) in chronic migraine prevention

Conditions: Treatment for Prevention of Chronic Migraine

Summary: to evaluate the effect of erenumab compared to placebo on the change from baseline in the number of monthly migraine days in adults with chronic migraine.

this study consisted of the following phases: screening, 4-week baseline phase, 12-week double-blind treatment, and 12-week follow-up. participants may have elected to participate in the optional pharmacokinetic substudy and the optional, novel patient-reported outcome (pro) assessment substudy. participants who completed the 12-week double-blind treatment phase of study 20120295 were eligible to enroll in an open-label extension study (study 20130255; nct02174861).

Eligibility criteria:
inclusion criteria: * history of at least 5 attacks of migraine without aura and/or migraine with visual sensory, speech and/or language, retinal or brainstem aura. * history of ≥ 15 headache days per month of which ≥ 8 headache days were assessed by the subject as migraine day. * ≥ 4 distinct headache episodes, each lasting ≥ 4 hours or if shorter, associated with use of a triptan or ergot-derivative on the same calendar day based on the ediary calculations. * demonstrated at least 80% compliance with the ediary. exclusion criteria: * history of cluster headache or hemiplegic migraine headache * unable to differentiate migraine from other headaches * failed \> 3 medication categories due to lack of efficacy for prophylactic treatment of migraine . * received botulinum toxinin head or neck region within 4 months prior to screening. * used a prohibited migraine prophylactic medication, device or procedure within 2 months prior to the start of the baseline phase

Keywords: chronic migraine
effects of water-based exercise on lipid profile and lipoprotein lipase of dyslipidemic premenopausal women

Conditions: Dyslipidemia

Summary: the aim of this study was to investigate the effects of water-based exercises on lipid profile (lp) and lipoprotein lipase (lpl) levels in premenopausal dyslipidemic women. it was hypothesized that a water-based aerobic interval-training period would decrease plasma concentrations of atherogenic lipoproteins and concomitantly increase hdl and lpl levels, as well as maximal oxygen uptake (vo2max) values.


Eligibility criteria:
inclusion criteria: * premenopausal * sedentary * dyslipidemic * aged between 40 and 50 years old exclusion criteria: * smokers * hypolipemic drugs users
effects of cognicise and arch support insoles in older adults with mild cognitive impairment

Conditions: Mild Cognitive Impairment

Summary: the purpose of this study aims to explore the surplus effect of arch support insole to a cognicise training program on lower-extremity function in community-dwelling older adults with mild cognitive impairment (mci). in this randomized controlled intervention study, we will recruit 40 community-dwelling individuals aged ≥55 years with mci. experimental group (n=20) will receive cognicise training program with insole intervention (6 hours/day), while the control group (n=20) only undergo cognicise training. a 1-h training session will be given three times a week for 12 weeks for both groups. the outcomes include static standing balance, functional reach test, timed-up-and-go test, 10-m obstacle crossing, the short physical performance battery (sppb), and gait assessment during single- and dual-task walking for 20 m at self-selected comfortable pace while performing serial subtractions (cognitive interference) or carrying a tray (motor interference). the results of the current study are expected to provide evidences in supporting the use of arch support insole among community-dwelling older adults with mci. interventions combing physical-cognitive training and insole for providing mechanical stability and somatosensory stimulation may serve as potential strategies for fall prevention.


Eligibility criteria:
inclusion criteria: * (1) aged 55 years and over; (2) able to walk more than 20 m without walking aids; (3) had a montreal cognitive assessment (moca) score lower than 26 ; (4) had self-reported memory complaints; and (5) had the ability to perform adls. exclusion criteria: * (1) dementia; (2) a history of malignant tumors ; (3) the presence of an unstable neurological or orthopedic disease, or visual problems interfering with participation in the study; and (4) an education level less than 6 years (elementary school).
effect of early coma arousal therapy on conscious level recovery and cognition in traumatic brain injury

Conditions: Traumatic Brain Injury With Loss of Consciousness

Summary: purpose: the aim of this study is to investigate the effect of early coma arousal therapy on conscious level and cognitive function in sever traumatic brain injury patients. background: traumatic brain injury (tbi) could be simply defined as an alteration in brain function due to external forces and is considered as one of the leading cause of death and disability worldwide, especially among young adults and the elderly. current estimates imply that annual incidence of tbi is 50-60 million worldwide, and specifically for europe and usa, 0.5% of europeans and 1.1% of americans are experiencing a tbi each year. the original scale has since been revised and is known as the rancho los amigos revised scale (rlas-r). one of the limitations of the original eight level scale was that it did not accurately reflect the individuals with higher levels of recovery. two more levels were added to the initial eight level ranchos scale to create a more comprehensive ten level scale named the rancho los amigos revised scale (rlas-r).

the aim of this study is to examine the early effect of coma arousal therapy on conscious level recovery and cognition in traumatic brain injury. forty two patients will be selected and they will be assigned in to two different group, a study group where will they recieve coma arousal therapy in addition to conventional therapy and a control group where they will recieve only the conventional physical therapy program.

Eligibility criteria:
inclusion criteria: 1. both genders. 2. traumatic brain injury with gcs score 3-12. 3. age range from 20-50 years old. 4. must be medically stable post trauma 29 exclusion criteria: 1. patient with other neurological deficits or orthopedic abnormalities that causing disability. 2. patients with pre injury psychiatric disorders. 3. patients with pre injury cognitive disorders. 4. patients who performed surgery post traumatic brain injury. 5. patients not taking the same medications.
efficacy and safety of 2 raltegravir doses in naive hiv-1-infected patients receiving rifampin for active tuberculosis

Conditions: HIV Infections; Tuberculosis

Summary: raltegravir is a potent antiretroviral agent that could be used as an alternative to efavirenz in hiv-1 infected patients with tuberculosis. however due to pharmacokinetic interactions, the optimal dose of raltegravir to be used in combination with rifampin is currently unknown. this phase ii open-label randomized multicenter trial is designed to estimate the antiviral efficacy of two doses of raltegravir and one dose of efavirenz at week 24, in hiv-1 naive patients co-infected with active tuberculosis (tb) treated with rifampin.


Eligibility criteria:
inclusion criteria: * adult patients (at least 18 years old) * plasma hiv rna \> 1000 copies/ml * hiv-1-infection confirmed by elisa and western blot or immunofluorescence * art naïve patients or * art for less than 3 months and more than 6 months ago ; an hiv resistance genotype at baseline showing no mutation to nnrti and tdf or 3tc will be required * for women of childbearing age, negative urinary test for pregnancy and to accept contraceptive methods: condom use and intra-uterine device when possible or declare no wish of pregnancy in the coming year. * confirmed or probable tb * tb treatment including rifampin started since 2 to 8 weeks before randomisation * signed informed consent form * for french patients, to be affiliated to the national health care system exclusion criteria: * hiv-2 infection (single or with hiv-1) * woman who is pregnant or likely to become so, is breastfeeding or refuses to use contraception * alt\>2.5n, hb \ 5n, lipase \>3n * creatinine clearance \<60ml/min as assessed by the cockcroft method * ongoing psychiatric pathology or any condition (including, but not limited to, the consumption of alcohol or drugs) which might, in the investigator's opinion, compromise the safety of treatment and/or patient compliance with the protocol * concomitant treatments including phenytoin or phenobarbital (compounds interacting with ugt1a1) * prior tb with a mycobacterium tuberculosis strain resistant to rifampin * tb treatment started for more than 8 weeks before randomisation

Keywords: hiv tuberculosis pharmacokinetics raltegravir france brazil treatment naive
neurotrophic factors in cerebrospinal fluid in diabetic patients with polyneuropathy

Conditions: Insulin-like Growth Factor I; Insulin-like Growth Factor II; Diabetes Complications; Polyneuropathies; Nerve Growth Factors

Summary: background: the pathogenetic factors underlying development of diabetic polyneuropathy (dp) remain unclear. reduced neurotrophic stimulation has been proposed as a possible mechanism. the neurotrophic factors igf i and ii, scd-163, ngf, vegf and bdnf are essential for development and regeneration of the nervous system. in earlier studies reduced concentrations of igf-i and ii in blood and reduced concentrations of ngf and bdnf in muscle and skin biopsies have been found in patients with dp. purpose: our purpose is to determine the concentration and biological activity of insulin-like growth factor i and ii (igf-i and ii), soluble cluster of differentiation 163 (scd-163), nerve growth factor (ngf), vascular endothelial growth factor (vegf) and brain-derived neurotropic factor (bdnf) in cerebrospinal fluid and in blood in patients with diabetes and/or nerve disease (especially diabetic polyneuropathy) as well as in healthy control subjects. we will furthermore relate the findings to peripheral nerve function. in addition the composition of the cerebrospinal fluid will be analyzed using mass spectrometry. hypothesis: we hypothesize that dp develops due to reduced concentration and biological activity of neurotrophic factors. we expect the concentration of igf-i and ii, vegf, ngf and bdnf to be reduced in cerebrospinal fluid in patients with dp compared to diabetic patients without damage to the nervous system and healthy control subjects. methods: study subjects consists of patients from department of neurology and department of department of clinical medicine (endocrinology and diabetes) aarhus university hospital, denmark, who are having a lumbar puncture performed.


Eligibility criteria:
inclusion criteria: * patients with diabetic polyneuropathy * patients with diabetes without peripheral nerve disorder * patients with polyneuropathies not due to diabetes * patients not suffering from diabetes or nerve disease (control subjects) * patients with unspecified nerve disease exclusion criteria: * other causes to the development of polyneuropathy in patients with diabetic polyneuropathy * cerebral infections

Keywords: vascular endothelial growth factor brain-derived neurothropic factor diabetes mellitus cd-163 cerebrospinal fluid peripheral nervous system diseases mass spectrometry
diagnostic performance of contrast-enhanced mammography

Conditions: Mammography

Summary: contrast-enhanced mammography (cem) is a functional breast imaging technology. like magnetic resonance imaging (mri), cem neovascularization enhancement can improve cancer detection rates, while lack of enhancement may lead to benign determination. the advantages of cem are dramatically apparent in women with dense breasts. the purpose of this study was to investigate the additional diagnostic value of cem added to the standard practice of mammography plus ultrasonography(us) in patients with suspicious breast lesions. this study was a single-center prospective-retrospective combined observational study. in the prospective part, women with suspected breast abnormalities undergo prospective cem evaluation, including acquisition of low energy (le) images and recombined images (ri) showing enhancement, concurrently with breast us. the retrospective part selected the mammography and breast us data of female patients with suspected breast abnormalities who had previous baseline matching.


Eligibility criteria:
inclusion criteria: * breast ultrasound or/and general mammography suggest that the lesion is bi-rads 4 or above; * willing to undergo enhanced mammography examination; * agree to perform tumor core needle biopsy or excisional biopsy to confirm pathological diagnosis when necessary. exclusion criteria: * allergy to iodinated contrast; * pregnant and lactating women; * suffering from kidney disease or abnormal kidney function, or undergoing renal dialysis; * the breast is too large to be completely included in the full-field mammography examination at one time; ○5 those with breast implants.

Keywords: breast cancer breast ultrasound contrast enhanced mammography
muscle strength and total knee replacement

Conditions: Arthropathy of Knee; Osteo Arthritis Knee

Summary: purposes: to compare knee extensor muscle strength, physical function and self-reported function before and after total knee replacement with healthy age-matched controls. to describe changes in knee extensor muscle strength up to one year after surgery. to study the relationship between changes in knee extensor muscle strength and changes in physical function, self-reported function and physical activity level and the relationship between changes in knee extensor muscle strength and satisfaction. methods: a prospective observational study and comparison with controls. 50-55 individuals aged 65 or older, scheduled for total knee arthroplasty will be recruited to the study group. measurement of study group 0-2 weeks before surgery and 3, 6 and 12 months following surgery. comparison with 50-55 healthy age-matched controls.


Eligibility criteria:
inclusion criteria: * scheduled for total knee replacement on the basis of osteoarthritis of the knee * expected rehabilitation in a primary care setting exclusion criteria: * difficulties reading or speaking swedish * revision surgery * rehabilitation in other settings than primary care
influence of catheter-based renal denervation in diseases with increased sympathetic activity

Conditions: Hypertension; Heart Failure; Chronic Kidney Disease; Diabetes; Heart Rhythm Disorders

Summary: the study is aiming to document the long-term safety and effectiveness of renal denervation in patients with hypertension and other diseases characterized by elevated sympathetic drive. catheter-based renal denervation will be performed using ce marked, percutaneous, systems.

inclusion criteria 1. individual is 18 years of age. 2. individual agrees to have all procedures performed, and is competent and willing to provide written, informed consent to participate in the registry. 3. patient scheduled for renal sympathetic denervation using market-released device. exclusion criteria 1. in the eyes of the treating physician, the renal artery anatomy would interfere with safe cannulation of the renal artery or meets local standards for surgical repair. 2. individual has any serious medical condition, which in the opinion of the treating physician may adversely affect the safety and/or effectiveness of the participant (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, significant anemia, etc.).

Eligibility criteria:
inclusion criteria 1. individual is 18 years of age. 2. individual agrees to have all procedures performed, and is competent and willing to provide written, informed consent to participate in the registry. 3. patient scheduled for renal sympathetic denervation using market-released device. exclusion criteria 1. in the eyes of the treating physician, the renal artery anatomy would interfere with safe cannulation of the renal artery or meets local standards for surgical repair. 2. individual has any serious medical condition, which in the opinion of the treating physician may adversely affect the safety and/or effectiveness of the participant (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, significant anemia, etc.).

Keywords: hypertension heart failure sympathetic activity